Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00527449
Status:
COMPLETED
Last Update Posted:
2010-01-15
First Post:
2007-09-07
Brief Title:
Neoadjuvant Chemotherapy of Primary Breast Cancer With EpirubicinDocetaxel and CarboplatinDocetaxel
Sponsor:
Klinikum Weissenfels
Organization:
Klinikum Weissenfels
Study Overview
Official Title:
Neoadjuvant Chemotherapy With 3x EpirubicinDocetaxel Followed by 3x CarboplatinDocetaxel in Patients With Primary Breast Cancer
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETCat01
Brief Summary:
The purpose of this study is to optimize results in neoadjuvant chemotherapy of local advanced primary breast cancer Therefore patients become first 3 cycles of EpirubicinDocetaxel followed by 3x CarboplatinDocetaxel
Detailed Description:
Most of the women who are diagnosed with breast cancer are in the situation that an operation is possible Using a neoadjuvant therapy the rate of breast-conserving surgery can be extended and tumor cell proliferation may be inhibited Further the neoadjuvant chemotherapy is an in-vivo-activity-test for the used drugs Epirubicin Docetaxel and Carboplatin have shown antineoplastic activity against solid cancer alone and in combination
Using two different combinations of these three drugs first 3 cycles EpirubicinDocetaxel and then changing to CarboplatinDocetaxel for 3 further cycles it is assumed that the results of the therapy will improve Main criterion is the determination of pCR second criteria are the rate of breast-conserving surgery tumor response and therapy-dependent toxicities
Using two different combinations of these three drugs first 3 cycles EpirubicinDocetaxel and then changing to CarboplatinDocetaxel for 3 further cycles it is assumed that the results of the therapy will improve Main criterion is the determination of pCR second criteria are the rate of breast-conserving surgery tumor response and therapy-dependent toxicities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None